drugset / Trial / NCT05047445
A First Time in Human Phase 1 Open-Label Study of the COVIDITY Vaccine Administered by Needle-free Injection
RandomizedParallel-groupOpen-labelPrevention
Summary
The main objectives of this study are to assess the safety, tolerability and immunogenicity of the candidate SARS-CoV-2 vaccine, COVIDITY, when administered using a needle-free ID or IM injection device.
Timeline
- Start
- 2021-10-01
- Primary completion
- 2022-12
- Completion
- 2022-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SCOV1 | Vaccine | 0.2 mg | Intramuscular |
| Subject | SCOV1 | Vaccine | 1 mg | Intramuscular |
| Subject | SCOV2 | Vaccine | 0.2 mg | Intramuscular |
| Subject | SCOV2 | Vaccine | 0.8 mg | Intramuscular |
| Subject | SCOV2 | Vaccine | 1 mg | Intramuscular |
| Subject | SCOV2 | Vaccine | 4 mg | Intramuscular |